BIOSTATISTICS / BIOINFORMATICS SHARED RESOURCE (Core-667) ABSTRACT Overview: The University of Colorado Cancer Center (UCCC) Biostatistics and Bioinformatics Shared Resource (BBSR) provides biostatistical and bioinformatics leadership and analytic support for laboratory- based cancer research, experimental therapeutic studies and clinical trials, as well as population-based studies (e.g., epidemiological, health outcomes and disparities research in our catchment area), to UCCC members. Expertise: Substantial expertise is available for the analysis of clinical trials, statistical genetics, next- generation sequencing, predictive modeling, cancer-focused bioinformatics, and health services research. Services: BBSR support of UCCC members begins with study design to address research questions, along with sample size determination and analytical plans, as needed for grant and clinical trial development and protocol submission. BBSR support also includes data and safety monitoring of clinical trials analysis, and assistance with manuscript preparation in relation to data interpretation and scientific conclusions. The BBSR actively participates in the Protocol Review and Monitoring System (PRMS) and Data and Safety Monitoring Committees (DSMC). The BBSR collaborates with other UCCC Shared Resources (particularly Genomics and the Molecular Pathology Shared Resources) in research studies and the development of new bioinformatic pipelines. Consultation and Education: Faculty biostatisticians and bioinformaticists also provide educational opportunities, through one-on-one training in biostatistics and bioinformatics, and are engaged in consultation with investigators and in the development of novel methods and tools that directly enhance UCCC member research. Management: The BBSR is comprised of two distinct components ? biostatistics and bioinformatics. Biostatistics is a UCCC Shared Resource while bioinformatics is an institutional core. Both are managed by UCCC; and both are overseen by the Associate Director for Population Sciences. Use of Services: Since July 2011, 252 investigators have used BBSR services. Sixty-seven percent of users (169) were UCCC members, representing all 6 Programs and resulting in 112 peer-reviewed publications. CCSG funding represents 25% of the annual operating budget. The remaining support comes from institutional support (43%), the CCTSI (4%) and user fees (28%). Future Directions: In the next 5 years, the BBSR will increase bioinformatics staff to accommodate the predicted growth of research projects that generate high-dimensional data. Future hires in bioinformatics will leverage resources with the newly-formed Division of Biomedical Informatics and Personalized Medicine (BIPM). Biostatistics staff hires will also be needed to accommodate planned growth in Population Sciences and clinical research including trials. Supporting the initiatives that form the Future Directions in the Director's Overview, the BBSR anticipates playing an important role in the Overcoming Resistance to Targeted Agents, the Promoting Healthy Living Initiative and the Front Range Clinical Trials Network, the latter requiring biostatistical expertise in multisite cancer clinical trial design.